Study on SAFE Nerve Sparing Technique Guided by Micro-Ultrasound for Prostate Surgery

Sponsor: Icahn School of Medicine at Mount Sinai

Sponsor score: 0

ClinicalTrials ID:NCT06945315

This clinical trial is testing a new technique called SAFE, which uses micro-ultrasound guidance during prostate surgery to help preserve nerve function and improve recovery of erectile function after surgery.

Patient Parameters

Program Overview

This study is exploring a new method to improve outcomes after prostate surgery, specifically focusing on reducing erectile dysfunction and urinary incontinence, which are common issues after surgery. The technique, called SAFE, uses a high-resolution micro-ultrasound to guide the surgeon during the procedure, aiming to protect the nerves around the prostate. This approach is being tested in patients undergoing robotic-assisted prostate surgery to see if it helps in better recovery of erectile function.

Eligibility Criteria

Inclusion Criteria

  • Men over 18 years old.
  • Men who are sexually active and have a certain level of erectile function (SHIM score of 17 or higher).
  • Men scheduled for specific types of nerve-sparing prostate surgery.
  • Must be able to understand and agree to the study by signing a consent form.

Exclusion Criteria

  • Men who need a second prostate surgery (salvage RALP).
  • Men currently receiving hormone therapy for prostate cancer.
  • Men who cannot take certain medications for erectile dysfunction (PDE5 inhibitors).

Locations

FACILITYZIPCITYSTATE
Mount Sinai Hospital10029New YorkNew York

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